Intracranial Pressure After Decompressive Craniectomy

December 1, 2017 updated by: Alexander Lilja-Cyron, Rigshospitalet, Denmark
Observational study to investigate the natural course of intracranial pressure (ICP) after decompressive craniectomy (DC) using long-term telemetric ICP monitoring. Patients will have continuous ICP measurement performed during the admission to the neuro-intensive care unit (NICU) and after discharge weekly measurements sessions will be performed before and after cranioplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several studies have investigated and documented the effect of DC in lowering ICP in intracranial hypertension following acute brain injuries, e.g. severe traumatic brain injury. But the natural course of ICP in these patients after the acute phase in the NICU has never been investigated. Clinical experience suggests that a DC affects cerebrospinal fluid circulation and ICP, e.g. causing hydrocephalus or subdural hygromas.

The aim of this observational study is to document the natural course of ICP following DC and to investigate the effect of cranioplasty on ICP. This is done by implantation of a telemetric ICP sensor and weekly follow-up monitoring sessions after discharge from the NICU until 1 month after cranioplasty. The monitoring sessions will include standardized body positions to investigate postural ICP changes before and after cranioplasty. The project will also provide experience with telemetric ICP monitoring during the acute phase in a NICU setting.

Study Type

Observational

Enrollment (Actual)

17

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients scheduled for a decompressive hemicraniectomy for elevated ICP (e.g. following severe traumatic brain injury) or signs of intracranial herniation (e.g. following cerebral edema in patients with middle cerebral artery infarction).

Description

Inclusion Criteria:

  • age > 18 years
  • scheduled for a decompressive hemicraniectomy for elevated ICP or signs of intracranial herniation

Exclusion Criteria:

  • skin damage in the frontal area where the telemetric ICP sensor is implanted
  • lack of informed consent from next-of-kin or the patient's general practitioner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial pressure variations
Time Frame: Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty
ICP is measured in standardized body positions to investigate postural changes after decompressive craniectomy and following cranioplasty
Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

July 30, 2017

Study Completion (ACTUAL)

July 30, 2017

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (ACTUAL)

December 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 6, 2017

Last Update Submitted That Met QC Criteria

December 1, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICPinDCv1.1
  • H-15009654 (OTHER: The Regional Committee on Health Research Ethics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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